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- A detailed review of the overall landscape of bispecific antibody therapeutics, including information on drug developers, phase of development (marketed, clinical, and preclinical / discovery) of the pipeline candidates, target antigen, type of antibody format, mechanism of action, target disease indication(s), therapeutic area, broader disease segment, route of administration, mode of administration and patient segment.
- A comprehensive list of novel technology platforms that are either currently available or being developed by various firms for the generation of bispecific antibody therapeutics, along with detailed profiles of key technologies. The chapter also includes an insightful competitiveness analysis, featuring a three-dimensional bubble representation that highlights the key technologies that are being used for the development of bispecific antibodies, taking into consideration the early stage (discovery, preclinical, IND and phase I) and late stage (phase II and above) development activity based on the technology (in terms of the number of drugs across different phases of development), number of partnerships established related to the technology and size of the developer company. In addition, it consists of a schematic world map representation, highlighting the geographical locations of technology developers engaged in this domain.
- Detailed profiles of marketed and clinical stage (phase II and phase III) bispecific antibody therapeutics. Each profile features an overview of the drug, details of the developer, along with its financial performance, mechanism of action and targets, dosage information, current clinical development status, development process, as well as details on annual sales (wherever available).
- Key takeaways from the bispecific antibody therapeutics pipeline, featuring a [A] grid analysis, representing the distribution of the pipeline (on the basis of mechanisms of action of product candidates) across different therapeutic areas and stages of development, [B] a five-dimensional spider-web analysis, highlighting the most popular mechanisms of action based on a number of relevant parameters, including number of bispecific antibodies in early stage (phase I) and late stage of development (phase II and above), number of ongoing clinical trials, target therapeutic areas and the number of companies that are developing these molecules, [C] a two-dimensional scattered plot competitiveness analysis, for the various target combinations for clinical-stage bispecific antibodies and [D] the chapter also includes an insightful summary representation using the logos of different industry stakeholders, highlighting the distribution of companies based on the company size.
- An analysis of the big biopharma players engaged in this domain, featuring a heat map based on various parameters, such as number of bispecific antibody therapeutics under development, target antigen, type of antibody format, mechanism of action and target therapeutic area.
- An analysis of recent partnerships and collaboration agreements inked in this domain since 2016, covering research collaborations, product and technology licensing agreements, product development and commercialization agreements, manufacturing agreements, mergers / acquisitions, joint ventures, product development agreements and other deals.
- A review on the key steps involved and challenges associated with the manufacturing of bispecific antibodies. In addition, it includes a list of contract manufacturing organizations (CMOs) and contract research organizations (CROs). The chapter also highlights the key considerations for bispecific antibody developers while selecting a suitable CRO / CMO.
- A clinical trial analysis of ongoing and planned studies related to bispecific antibody therapeutics, taking into consideration a number of relevant parameters, including trial registration year, trial recruitment status, trial phase, trial design, disease indication(s), focus therapeutic area, most active industrial and non-industrial players, and geographical location of the trial.
- A review of the key promotional strategies that have been adopted by the developers of the marketed bispecific antibodies, namely Blincyto® and Hemlibra®. It includes a detailed comparison of both the drugs based on the information available on their respective websites, such as patient support offerings, informative downloadable content, and product visibility in scientific conferences.
- A discussion on important, industry-specific trends, key market drivers and challenges, under a SWOT framework, featuring a qualitative Harvey ball analysis that highlights the relative impact of each SWOT parameter on the overall market.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
- Therapeutic Area
- Autoimmune Disorders
- Eye Disorders
- Genetic Disorders
- Hematological Malignancies
- Infectious Diseases
- Inflammatory Disorders
- Skin Disorders
- Mechanism of Action
- Cytokines Retargeting / Neutralization
- Dual Ligands Blocking
- T-cell Retargeting / Activation
- Target Antigens
- CD3 x CD19
- CD30 x CD16A
- Factor IXa x Factor X
- IL-1α x IL-1β
- IL-13 x IL-4
- IL-17A x Albumin
- IL-17A x IL-17F
- Psl x PcrV
- VEGF-A x ANG2
- Key Players
- Astra Zeneca
- Taisho Pharmaceutical
- Key Geographical Regions
- North America
The report features inputs from eminent industry stakeholders, according to whom this relatively novel class of antibody therapeutics is likely to garner significant interest among therapy developers and end users alike. The report includes detailed transcripts of discussions held with the following experts:
- Martin Steiner (Chief Executive Officer, Synimmune)
- Ludger Große-Hovest (Chief Scientific Officer, Synimmune)
- Jane Dancer (Chief Business Officer, F-Star)
- Siobhan Pomeroy (Senior Director, Business Development, Cytom X)
- Yinjue Wang (Associate Director, Process Development, Innovent Biologics)
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Key Questions Answered
- What are the key technologies used for the development of bispecific antibodies?
- What are the key biological target combinations and antibody formats that are being explored for bispecific antibody development?
- Who are the leading industry and non-industry players engaged in this market?
- What kind of partnership models are commonly adopted by bispecific antibody developers?
- Which CMOs offer services for manufacturing bispecific antibodies?
- What are the regulatory guidelines issued by different organizations related to the development of bispecific antibodies?
- What kind of promotional strategies are being used by developers of marketed bispecific antibody developers?
- How is the current and future market opportunity (related to bispecific antibodies) likely to be distributed across key market segments?
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